The Use of High Concentration Hyaluronic Acid (HA) Transfer Medium in Repeated Implantation Failure (RIF) Patients

Last updated: April 11, 2024
Sponsor: University Hospital, Ghent
Overall Status: Active - Recruiting

Phase

N/A

Condition

In Vitro Fertilization

Treatment

EmbryoGlue®, Vitrolife

Conventional Transfer

Clinical Study ID

NCT04709796
BC-08429
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (EmbryoGlue®, Vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The trial only includes women with a clinical indication for ART with a history of RIFdefined as the absence of implantation after two consecutive cycles of IVF, ICSI orfrozen embryo replacement cycles where the cumulative number of transferred embryoswas no less than four for cleavage-stage embryos and no less than two for blastocysts,with all embryos being of good quality and of appropriate developmental stage. Furthermore, other specific 'RIF' investigations were performed and treated if necessary:
  • Normal hysteroscopy
  • Normal karyotype of both parents
  • Coagulation screening (Antitrombine II deficiency, Factor VIII augmentation, APCresistance, Factor V + Factor II augmentation, Protein S and C deficiency anhomocysteine augmentation)
  • Auto-immune screening (Lupus anticoagulant, Rheumatoid Factor, Anti-nuclearantibodies, Anti-cardiolipine antibodies and Glycoprotein-1-antibodies)

Exclusion

Exclusion Criteria:

  • • Simultaneous participation in another clinical study
  • Untreated and uncontrolled thyroid dysfunction
  • Tumors of the ovary, breast, uterus, pituitary or hypothalamus
  • Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause
  • Ovarian cysts or enlarged ovaries
  • Malformations of the reproductive organs
  • Moderate or severe hepatic impairment
  • Current use of oral contraceptives, anti-psychotics, anti-epileptics orchemotherapy
  • Patients who undergo preimplantation genetic testing (PGT), fertilitypreservation or oocyte donation
  • Couples needing TESE/MESA material

Study Design

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: EmbryoGlue®, Vitrolife
Phase:
Study Start date:
March 03, 2021
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • UZ Ghent

    Ghent, 9000
    Belgium

    Active - Recruiting

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